Releasing press releases.
On January 20th 2010, Novartis announced that:
- TRANSFORMS and FREEDOMS were being published in the New England Journal of Medicine (NEJM).
- It had filed an NDA (New Drug Application) for Fingolimod (FTY720) with the FDA (U.S. Food and Drug Administration) and an MAA (Market Authorization Application) with the EMEA (European Medicines Agency) in DECEMBER 2009.
Huh?
Some may be surprised that Novartis didn't announce this important piece of information when it had filed the regulatory documents, but another way of looking at it is that Novartis did exactly what it said it would:
It submitted the regulatory documents / applications before the end of 2009.
I can't say I was surprised when I heard that the filing had been in December 2009, I just was unable to scoop the news because I also believe in doing what I promised:
To not blog or tweet about the December filing prior to the press release.
Novartis -- I kept my promise, now please keep yours and continue to support the MS community through research and education.
Stay transparent and keep looking for the lowest dose of Fingolimod that is still highly effective while being even safer.
Now we really may see the first Oral MS Drug.
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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I was diagnosed with MS about four years ago and I've been on Avonex, Copaxone and Tysabri with little to no success. I'm on a pill right now called low-dose naltrexone (LDN). It's used off label for autoimmune diseases like mine. I've been on it eight months, and it has done more for me than any conventional medication. I have regained feeling throughout my body, my bladder function has returned to almost normal, it has given me more energy, and I'm able to walk farther distances with my cane.
ReplyDeleteI say there already is an oral medication out there for patients. Plus, LDN doesn't have the side effects like the other ones. I encourage a discussion among doctors and their patients about this medication.
Dr. Kantor, have you heard of LDN and if so, have you prescribed it?
Regards,
Sherri
Thank you for the comment.
ReplyDeleteI certainly have heard of and used LDN -- I direct you to the featured video on the front page of our website (www.neurologique.org), which is precisely on LDN.
Also, even if you do consider LDN a 'disease modifying agent' (without controlled studies, then it is not the first because we are discussing the firt oral medication to be FDA approved for that indication (and LDN is not yet FDA approved for MS).
There have been some small scale studies on LDN in MS. In the Buce Cree study from UCSF, LDN improved quality of life (they didn't measure the aspects of MS that we use to judge whether it modifies the disease) and in the Comi study from Italy, LDN helped spasticity.
So, more studies are needed to better answer the question of LDN's role in MS for most people (for you, it seems to be working great and I am glad about that -- as you undoubtedly are).
Thanks for the comment. I'm very familiar with the study done at UCSF. I actually see a neurologist there. They are very good about discussing LDN with their patients. They would like to do a larger study, so they have applied for funding through the NMSS. The first study was patient-funded and they were not able to conduct MRIs or do a larger study because of the amount of money they had to work with(somewhere around $20,000).
ReplyDeleteI'm just amazed at what is has done for me. I went in with the expectation that it would help fatigue, but nothing else. I was pleasantly surprised! I just wish I would had known about LDN before I started the CRAB-T drugs. Perhaps it would have stopped the progression of the disease at an earlier stage.
Once again, thanks for your response. And I do understand the difference between the FDA vs. non-FDA comment. :)It's time to get LDN FDA-approved.